The Centre for Science in the Public Interest (CSPI)(1) is pleased to submit the following
comments in response to Health Canada's Discussion Paper on health claims. CSPI is uniquely
suited to providing comments on this issue. We have worked extensively on this matter since 1985
when the U.S. Food and Drug Administration (FDA) first proposed permitting health claims on food
labels. CSPI participated in all FDA proceedings, worked closely with members of Congress, and
became the leading proponent of the Nutrition Labeling and Education Act (NLEA) of 1990, which
specified the basis for the current regulatory scheme for health claims in the U.S. More recently,
CSPI has issued reports on the regulation of health claims in the UK and Japan, and has participated
in the debate over health claims at the Codex Alimentarius Commission.

In theory, the inclusion of health claims on food labels, if properly regulated, could
potentially benefit consumers by communicating educational information about the relationship
between certain nutrients or classes of foods and the incidence of diet-related diseases. In practice,
however, governments that have permitted health claims have faced insurmountable difficulties in
regulating manufacturers, and consumers in those countries have been exposed to many misleading
claims. Thus, we recommend that Health Canada postpone its proposal to permit health claims for
the following six specific reasons.

1. First, since Health Canada issued its final policy decision in the 1998 Policy Paper and stated in
the June 1999 Discussion Paper that it is "considering adopting generic health claims that are
authorized in the U.S.," the entire basis for regulatory control of health claims in the United States
has been severely undermined. A recent U.S. Court of Appeals decision, Pearson v. Shalala(2), which
became final on July 1, 1999, requires the U.S. FDA to permit health claims to appear on food labels
even if the agency believes that such claims are not scientifically valid. The ruling will certainly
impair the FDA's ability to control misleading claims and undermine the credibility of the entire
health claim system. Accordingly, we urge Health Canada to withdraw the now outdated Discussion
Paper and reevaluate its 1998 policy decision to adopt the U.S. model.

2. Second, the U.S. regulations permitting health claims were promulgated in conjunction with
regulations requiring mandatory nutrition labelling on all food labels. As the U.S. Congress
recognized, health claims alone could not be relied upon to educate consumers about the
relationship between diet and disease, but rather were one part of a multi-tiered program that also
involved mandatory nutrition labelling. Thus, Health Canada should not permit health claims until
full nutrition labelling is mandatory for all foods. The best way to educate consumers about
nutrition is not through health claims on a few select foods, but through mandatory nutrition
labelling on all foods. Consumers need standardized nutrition information about all food products  not just claims that a manufacturer chooses to highlight  in order to follow the advice of health
professionals and improve their diets. In contrast, any potential educational benefits from health
claims will be limited by the fact that health claim messages will likely appear only on
manufacturer-selected foods (i.e., a subset of those eligible to make the claims) and convey only
positive risk reduction messages, not increased health risk messages associated with foods that are
high in unhealthful nutrients or low in healthful nutrients.

In addition, establishing requirements for mandatory nutrition labelling will create a much
greater incentive than voluntary health claims for manufacturers to compete on the basis of health
and produce a wide variety of new, healthier, processed foods. In fact, that is exactly what happened
in the U.S. Since nutrition labelling became mandatory in 1994, manufacturers have reformulated
hundreds of food products and introduced more than 5,000 new low and reduced-fat foods, most of
which do not have health claims on the label. Contrary to Health Canada's examination of the
survey research in section 2.4.3 of its Discussion Paper, this development was directly linked to
requirements for mandatory nutrition labelling (and related requirements defining nutrition claims
like "low fat"), not health claims.

3. Third, the Codex Alimentarius Commission is currently developing international standards for
the regulation of health claims. Health Canada should delay setting standards for health claims until
a consensus develops in the international community about whether, and under what conditions,
such claims will be permissible in international trade. Because the experience of countries such as
the U.S. and Japan, which have permitted health claims, has been mixed, Canada should wait for the
guidance that will be provided by deliberations of the Codex Alimentarius Commission on this
issue.

4. Fourth, the original health claim provisions of the U.S. NLEA were enacted to curtail widespread
abuses by companies that had already begun using misleading health claims on food labels
throughout the 1980s. Because such abuses are not evident in Canada, and Health Canada's
authority to prevent abuses is clear, there is no urgency for regulatory intervention.
(3)

5. Fifth, since the benefits from health claim programs that have been implemented to date in the
U.S. and Japan have been, at best, minimal and there is little evidence of consumer demand for
seeing these statements on food labels, there is little cost to the public interest in delaying regulatory
intervention.

6. Sixth, CSPI remains concerned that, in the context of current fiscal limitations, Health Canada
and the Canadian Food Inspection Agency lack sufficient administrative, scientific and financial
resources to properly evaluate applications for pre-market approval and to adequately conduct
surveillance and enforcement measures to ensure that health claims used in advertising and on food
labels do not mislead consumers. Accordingly, we are concerned that, under pressure from the food
industry, Health Canada may be putting in place a health claims regime it has inadequate capacity to
administer, or that it plans to divert resources away from other programmes that have greater
potential for improving public health.

Without sufficient resources to properly monitor compliance and enforce standards designed
to safeguard the public health, even well designed regulations will be useless. Accordingly, CSPI
urges Health Canada to defer implementing a voluntary health claims programme until such time as
it has properly estimated the administrative and enforcement costs and determined that it is capable
of meeting those costs.

If Health Canada nonetheless decides to proceed, we recommend that health claims be very
strictly regulated, as set forth in Appendix A. We have also enclosed a copy of Functional Foods:
Public Health Boon or 20th Century Quackery which particularizes our concerns about problems
associated with health claims currently appearing on food labels and advertisements in Japan, the
U.K. and the U.S. CSPI's partner organization, the International Association of Consumer Food
Organizations, distributed this report at the 1999 meeting of the Codex Food Labelling Committee
in Ottawa.

Improving the public's health, not aiding the food industry's marketing objectives, must
remain Health Canada's only concern. We thank Health Canada for this opportunity to comment
and would like to offer our assistance to work toward a final resolution of this matter.

3. While most food manufacturers observe Canadian prohibitions on health claims, a number
of manufacturers of infant food and breast milk substitutes have begun to use risk reduction and
biological function claims which appear almost indistinguishable from health claims. We share the
concerns raised by INFACT Canada about this subject.